Dr. Reddy’s & Alvotech Partner to Develop Biosimilar to Keytruda, Expanding Oncology Portfolio

Dr. Reddy’s Laboratories Ltd. and Alvotech have entered into a strategic collaboration to co-develop a biosimilar candidate to Keytruda (pembrolizumab), marking a major milestone in oncology treatment accessibility. The partnership aims to accelerate biosimilar development, ensuring affordable immunotherapy options for cancer patients worldwide.

 

Key Highlights

 

Biosimilar Development & Regulatory Pathway:

 

The collaboration focuses on developing a biosimilar version of Keytruda, a leading monoclonal antibody therapy for multiple cancers.

 

Alvotech will handle development and manufacturing, while Dr. Reddy’s will oversee registration and commercialization in key markets.

 

Market Potential & Competitive Positioning:

 

Keytruda generated $25 billion in global sales in 2024, making it one of the highest-selling oncology drugs.

 

The biosimilar aims to reduce treatment costs, expanding access to life-saving immunotherapy.

 

Regulatory Progress & FDA Acceptance:

 

The U.S. FDA has accepted the Biologic License Application (BLA) for AVT03, a biosimilar to Prolia and Xgeva, developed under a previous Dr. Reddy’s-Alvotech partnership.

 

The companies are expected to follow a similar regulatory pathway for the Keytruda biosimilar, ensuring compliance with global standards.

 

Future Outlook & Industry Impact:

 

The collaboration reinforces Dr. Reddy’s commitment to biosimilars, strengthening its oncology portfolio.

 

Analysts expect biosimilars to drive cost-effective cancer treatments, benefiting patients and healthcare systems worldwide.

 

Dr. Reddy’s latest partnership with Alvotech marks a significant step in biosimilar innovation, ensuring affordable and accessible immunotherapy solutions.

 

Source:Alvotech News, CSIMarket, and Voice of Healthcare.